BACKGROUND: Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. OBJECTIVE: The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). DESIGN: Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. SETTING: The trial was conducted in 67 centers in 6 countries. MEASUREMENTS AND MAIN RESULTS: A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with >10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). CONCLUSIONS: Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial.
BACKGROUND: Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. OBJECTIVE: The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). DESIGN: Throughout the 4-year trial, research personnel approached eligible critically illpatients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. SETTING: The trial was conducted in 67 centers in 6 countries. MEASUREMENTS AND MAIN RESULTS: A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with >10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). CONCLUSIONS: Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial.
Authors: Jane Topolovec-Vranic; Marlene Santos; Andrew J Baker; Orla M Smith; Karen E A Burns Journal: Can Respir J Date: 2014-06-10 Impact factor: 2.409
Authors: Nick Daneman; Asgar H Rishu; Wei Xiong; Sean M Bagshaw; Deborah J Cook; Peter Dodek; Richard Hall; Anand Kumar; Francois Lamontagne; Francois Lauzier; John C Marshall; Claudio M Martin; Lauralyn McIntyre; John Muscedere; Steven Reynolds; Henry T Stelfox; Robert A Fowler Journal: Trials Date: 2015-04-18 Impact factor: 2.279
Authors: Jennie Johnstone; Maureen Meade; John Marshall; Daren K Heyland; Michael G Surette; Dawn Me Bowdish; Francois Lauzier; Lehana Thebane; Deborah J Cook Journal: Pilot Feasibility Stud Date: 2015-05-24
Authors: Nick Daneman; Asgar H Rishu; Ruxandra L Pinto; Yaseen M Arabi; Deborah J Cook; Richard Hall; Shay McGuinness; John Muscedere; Rachael Parke; Steven Reynolds; Benjamin Rogers; Yahya Shehabi; Robert A Fowler Journal: BMJ Open Date: 2020-05-11 Impact factor: 2.692
Authors: Waleed Alhazzani; Gordon Guyatt; John C Marshall; Richard Hall; John Muscedere; Francois Lauzier; Lehana Thabane; Mohammed Alshahrani; Shane W English; Yaseen M Arabi; Adam M Deane; Tim Karachi; Bram Rochwerg; Simon Finfer; Nick Daneman; Nicole Zytaruk; Diane Heel-Ansdell; Deborah Cook; On Behalf Of Journal: Ann Saudi Med Date: 2016 Nov-Dec Impact factor: 1.526
Authors: Sebastian Blecha; Susanne Brandstetter; Frank Dodoo-Schittko; Magdalena Brandl; Bernhard M Graf; Thomas Bein; Christian Apfelbacher Journal: BMJ Open Date: 2018-09-24 Impact factor: 2.692